"It is not the strongest or the most intelligent who will
survive but those who can best manage change." -- Charles
Darwin
In the patent world, today's change comes at the hands of the
America Invents Act (AIA). AIA established post-grant proceedings
in the U.S. Patent and Trademark Office (USPTO) that have emerged
as a battleground for pharmaceutical patent challenges in addition
to the usual district court venue. Those challenges come in the
form of inter partes review (IPR) and covered business method (CBM)
proceedings. The proceedings have had mixed results thus far.
Regardless of the outcomes and trends, innovator companies need to
remain vigilant, irrespective of the forum and adversary.
For example, in the first IPR decisions on Orange Book-listed
patents, the Patent Trial and Appeal Board (PTAB) sided with
branded pharma companies on patents owned by Supernus
Pharmaceuticals covering the rosacea drug Oracea®
(doxycycline), which is marketed by Galderma Laboratories. In the
December 2014 decisions in IPR2013-00368, IPR2013-00371, and
IPR2013-00372, the PTAB found that Petitioner Amneal
Pharmaceuticals had not shown that the challenged claims of three
patents listed in the Orange Book for Oracea® were
unpatentable. Amneal's petitions relied on the same prior art
cited to the USPTO during examination of the challenged patents and
asserted by Amneal during litigations in the District of Delaware.
The decisions focused on the construction of the claim term
"delayed release," which the PTAB construed according to
the broadest reasonable interpretation standard. The PTAB declined
to import a pH limitation from a preferred embodiment into the
claim term and thus determined that Amneal had not shown that the
prior art disclosed the "delayed release" claim
limitation.
In a January 2015 decision favoring the pharmaceutical patent
owner, the PTAB denied multiple requests for covered business
method (CBM) review of four Orange Book-listed patents owned by
Jazz Pharmaceuticals, Inc. in CBM2014-00151, CBM2014-00149,
CBM2014-00150, and CBM2014-00153. Jazz's patents are listed in
the Orange Book as covering XYREM® (sodium oxybate), used for
the treatment of narcolepsy to reduce excessive daytime (EDS)
sleepiness and sudden weak or paralyzed muscles (cataplexy). The
petitions, filed by Amneal Pharmaceuticals, Par Pharmaceutical, and
Roxane Laboratories, were the first attempts to use CBM review on
pharmaceutical patents. The challenged claims related to
computerized methods for controlling the distribution of XYREM®
(sodium oxybate), a drug with a high risk of abuse. The PTAB,
however, concluded that the petitioners failed to show that
Jazz's patents were "covered business method patents"
under the AIA and therefore denied review.
Yet in another set of recent decisions issued in February 2015, the
PTAB invalidated patents covering Genzyme Corp.'s enzyme
therapy drug Myozyme® (alglucosidase alfa) for the treatment of
Pompe disease, a glycogen storage disorder type II. Genzyme's
competitor BioMarin Pharmaceutical Inc. challenged the patents on
obviousness grounds in IPR2013-00534, IPR2013-00535, and
IPR2013-00537 in August 2013. The PTAB's decision invalidated
all challenged claims in what is considered to be the first IPR
final written decision in a biopharmaceutical case.
In addition to challenges from competitors and generic drug
manufacturers, non-industry stakeholders, such as hedge fund
managers, are targeting pharmaceutical patents. For example, IPR
petitions have been filed against patents owned by Acorda
Therapeutics, Allergan Sales, LLC, Shire PLC, and Jazz
Pharmaceuticals by non-industry stakeholders aiming to shake up the
financial markets by invalidating patents covering pharmaceutical
drugs. Of note for one of these petitions, the Federal Circuit
already affirmed the validity of the branded company's patent
directed to the treatment of glaucoma by administering two drugs in
a single composition, in Allergan, Inc. v. Sandoz Inc.,
No. 11-1619 (Fed. Cir. May 1, 2013). The petitioners apparently
aimed to take advantage of the differences between the PTAB's
broadest reasonable interpretation standard for claim construction
and the principles of claim constructions used by district courts
as set forth in Phillips v. AWH Corp., 415 F.3d 1303 (Fed.
Cir. 2005) (en banc). These apparent targeted filings demonstrate
the sea-change as a result of the post-grant proceedings.
While it is early to discern certain trends in these post-grant
proceedings, patent owners and branded pharma should be prepared
for challenges by these unfamiliar foes in addition to the usual
adversaries. It also goes without saying that one needs to consider
these type of attacks when evaluating a portfolio and prosecuting
applications likely to be subject to attack. This goes to the heart
of Darwin's quote. That is, today's portfolio management
and prosecution need to be just as inventive as the technology it
seeks to protect. For example, one needs to consider claim scope,
continuation practice, the use of information disclosure
statements, and other USPTO proceedings (supplemental examination,
Track One prioritized examination, etc.) in portfolio management
and prosecution. Seeking strong patent protection needs to be just
as proactive as those using these post-grant proceedings to
challenge pharmaceutical patents.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
